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IDH Inhibitor

AG-120 or AG-221 Combination Therapy for Acute Myeloid Leukemia

Phase 1

Waitlist Available

Research Sponsored by Institut de Recherches Internationales Servier

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed with previously untreated AML (excluding APL) with locally documented IDH1 and/or IDH2 gene mutation scheduled for induction therapy followed by consolidation therapy

Adequate renal function as evidenced by specific criteria

Must not have

Taking known strong CYP3A4 inducers, unless manageable

Uncontrolled active infection or invasive fungal infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 26 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying AG-120 and AG-221 to see if they are safe when given with standard AML induction and consolidation therapy and to find the maximum tolerated dose of each drug.

Who is the study for?

Adults with newly diagnosed Acute Myeloid Leukemia (AML) having specific mutations (IDH1/IDH2), who haven't had AML treatment but may have been treated for related conditions. They should be in a stable health condition, not pregnant or breastfeeding, and willing to use effective contraception.

What is being tested?

The trial is testing AG-120 or AG-221 combined with standard AML therapies during different phases of treatment. It aims to find the safest doses of these drugs when used with induction and consolidation therapy, followed by maintenance until relapse or unacceptable toxicity.

What are the potential side effects?

Potential side effects include reactions at the infusion site, changes in liver and kidney function tests, gastrointestinal symptoms like nausea and vomiting, potential blood disorders such as anemia or clotting issues, fatigue, and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have AML with an IDH mutation and haven't started treatment yet.

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My kidney function is within normal ranges.

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I am 18 years old or older.

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I can take care of myself and am up and about more than half of my waking hours.

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My liver is functioning well.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not on strong CYP3A4 inducers, or it can be managed.

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I do not have any uncontrolled infections or fungal infections.

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I have HIV or active hepatitis B or C.

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My leukemia is causing severe, life-threatening issues.

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I have issues that prevent me from taking or absorbing medication properly.

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I have symptoms or a diagnosis of leukemia in my brain or spinal cord.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 26 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 26 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 26 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Participants with Adverse Events (AEs)

Secondary study objectives

Pharmacokinetics (PK) of AG-120 and AG-221 in Plasma when Administered with Induction and Consolidation Therapy

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups

Experimental Treatment

Group I: AG-221 with cytarabine and idarubicinExperimental Treatment5 Interventions

Daily AG-221 administered orally in combination with standard Induction therapy and consolidation therapy. After 1 cycle of induction therapy, participants may undergo a second induction cycle given as per institutional practice. Participants who achieve an adequate response at the end of induction therapy will go on to receive consolidation therapy (mitoxantrone/etoposide or up to 4 cycles of cytarabine) in combination with AG-221. Participants who complete consolidation therapy and are in CR or CRi (including CRp) may continue on maintenance therapy and receive daily treatment with AG-221.

Group II: AG-221 with cytarabine and daunorubicinExperimental Treatment5 Interventions

Group III: AG-221 (starting on Day 8) with cytarabine and idarubicinExperimental Treatment5 Interventions

Daily AG-221 administered orally starting on Day 8 of induction cycle 1 in combination with standard Induction therapy and consolidation therapy. After 1 cycle of induction therapy, participants may undergo a second induction cycle given as per institutional practice. Participants who achieve an adequate response at the end of induction therapy will go on to receive consolidation therapy (mitoxantrone/etoposide or up to 4 cycles of cytarabine) in combination with AG-221. Participants who complete consolidation therapy and are in CR or CRi (including CRp) may continue on maintenance therapy and receive daily treatment with AG-221.

Group IV: AG-221 (starting on Day 8) with cytarabine and daunorubicinExperimental Treatment5 Interventions

Group V: AG-120 with cytarabine and idarubicinExperimental Treatment5 Interventions

Daily AG-120 administered orally in combination with standard Induction therapy and consolidation therapy. After 1 cycle of induction therapy, participants may undergo a second induction cycle given as per institutional practice. Participants who achieve an adequate response at the end of induction therapy will go on to receive consolidation therapy (mitoxantrone/etoposide or up to 4 cycles of cytarabine) in combination with AG-120. Participants who complete consolidation therapy and are in CR or CRi (including CRp) may continue on maintenance therapy and receive daily treatment with AG-120.

Group VI: AG-120 with cytarabine and daunorubicinExperimental Treatment5 Interventions

Daily AG-120 administered orally in combination with standard Induction therapy and consolidation therapy. After 1 cycle of induction therapy, participants may undergo a second induction cycle given as per institutional practice. Participants who achieve an adequate response at the end of induction therapy will go on to receive consolidation therapy (mitoxantrone/etoposide or up to 4 cycles of cytarabine) in combination with AG-120. Participants who complete consolidation therapy and are in complete response (CR) or complete remission with incomplete hematologic recovery (CRi) (including CR with incomplete platelet recovery \[CRp\]) may continue on maintenance therapy and receive daily treatment with AG-120.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

idarubicin

2007

Completed Phase 3

~5130

mitoxantrone

2005

Completed Phase 4

~1960